《人类遗传资源管理条例实施细则》政策解读与新时期的管理策略分析

Policy interpretation of the implementation Rules of the Regulations on the Management of Human Genetic Resources and analysis of the management strategies in the new era

目的通过解读《人类遗传资源管理条例实施细则》(以下简称为"《细则》"),为各机构在新时期开展人类遗传资源的规范化管理提供建议。方法梳理《细则》实施对人类遗传资源管理带来的挑战,结合实际工作经验讨论新时期人类遗传资源的管理策略。结果人类遗传资源管理在生物样本安全、数据管理、知识产权保护和项目过程管理等方面仍面临重大挑战。结论新时期各机构应加速生物样本平台和科研数据平台的建设,加强知识产权管理,优化项目过程管理,做好人类遗传资源管理和服务工作。

Objective To interpret the Implementation Rules of the Regulations on the Management of Human Genetic Resources(hereinafter referred to as the″Rules″),and to provide suggestions for further standardized management of human genetic resources in the new era.Methods The challenges brought by the implementation of the Rules were summarized,and management strategies for human genetic resources were provided.Results Human genetic resource management still faced significant challenges,including sample security,data management,intellectual property protection,and project process management.Conclusions In the new era,research institutions should accelerate the construction of biobanks and research data platforms,strengthen intellectual property management,and optimize project process management.